RMAT designation reinforces clinical significance of investigational biologic product TTAX02 used during in-utero fetal surgical repair of spina bifida
Miami, Fla. – April 16, 2020 – TissueTech, Inc., the pioneer in the development and clinical application of regenerative human birth tissue products, announced today that the U.S. Food and Drug Administration (FDA) has granted their cryopreserved human umbilical cord investigational biologic product TTAX02 RMAT designation for the treatment of spina bifida in-utero.
This designation aims to streamline development of regenerative medical products used in the FDA’s Investigational New Drug (IND) program for the treatment of serious or life-threatening diseases such as spina bifida. In spina bifida, the spinal canal opens along vertebrae in the lower or middle back of the fetus. It is the most common neural tube defect in the U.S. and is characterized by incomplete development of the brain, spinal cord, and/or protective covering around the brain and spinal cord.1
“Although rare, patients who suffer from open spina bifida have a ten times greater death rate than the national average from ages five to 40 years,”2 said Amy Tseng, TissueTech Co-Founder, President and Chief Executive Officer. “This RMAT designation highlights the need for an effective treatment for this life-threatening condition and the great potential TTAX02 holds.”
The benefits of in-utero fetal surgery are promising and include less exposure of the vulnerable spinal nerve tissue and bone to the intrauterine environment. Additionally, doctors have discovered that in-utero fetal surgical repair of spina bifida may positively affect fetal hindbrain development in-utero, decreasing the severity of certain complications—such as Chiari II and hydrocephalus—or reduce the need for surgery to implant a shunt.1
In addition to the RMAT designation, TissueTech is also planning to conduct a Phase 3 clinical trial to demonstrate the safety and efficacy of TTAX02 when used as a single patch to cover the neural placode, or a dual patch to close both the skin and meningeal defects during in-utero fetal surgical repair of spina bifida, to determine if it may improve clinically meaningful neurological outcomes after birth.
About TissueTech, Inc.
TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue, Inc., pioneered the development and clinical application of human birth tissue-based products. Founded in 1997, Bio-Tissue markets products for the ophthalmology and optometry markets; and Amniox markets products for use in the musculoskeletal and wound care markets. Clinicians have performed more than 500,000 human implants with the company’s products and published more than 360 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous use for promoting ophthalmic wound healing as acting as an anti-scarring, anti-inflammatory and anti-angiogenic agent and supporting epithelial adhesion and differentiation. Learn more at https://tissuetech.com/.
Physicians are encouraged to visit the TissueTech Physician Portal to learn more about TissueTech’s platform technology, review product application guides, and view educational webinars.